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FDA 510(k)

SINGLE USE SELDINGER/COURNAND PERC. NDL

K-Number: K810859 · 1981-04-11

ApplicantProcedure Products, Inc.
Decision Date1981-04-11
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SINGLE USE SELDINGER/COURNAND PERC. NDL is the device name listed in this FDA 510(k) record. The listed applicant is Procedure Products, Inc.. It received FDA 510(k) clearance on 1981-04-11 under 510(k) number K810859. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE USE SELDINGER/COURNAND PERC. NDL?

SINGLE USE SELDINGER/COURNAND PERC. NDL is a medical device that received FDA 510(k) clearance on 1981-04-11. The listed applicant is Procedure Products, Inc.. The 510(k) number is K810859.

When did SINGLE USE SELDINGER/COURNAND PERC. NDL receive FDA 510(k) clearance?

SINGLE USE SELDINGER/COURNAND PERC. NDL received FDA 510(k) clearance on 1981-04-11, under 510(k) number K810859.

Who is the listed applicant for SINGLE USE SELDINGER/COURNAND PERC. NDL?

The FDA 510(k) record lists Procedure Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINGLE USE SELDINGER/COURNAND PERC. NDL?

The FDA product code for SINGLE USE SELDINGER/COURNAND PERC. NDL is DRE.

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Other records listing Procedure Products, Inc. as applicant

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Related Devices (Code: DRE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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